Therapeutic cancer vaccine for gastric cancer patients

A Phase 2 Study to Evaluate the Safety and Immunological Efficacy of Therapeutic Cancer Vaccine (AST-301, pNGVL3-hICD) in Patients With HER2 Expressing Gastric Cancer (CORNERSTONE-003)

This study is testing a new cancer vaccine for people with gastric cancer to see if it helps them stay healthy longer and is safe to use.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: Aston Sci. Inc. (Industry-sponsored)
• Locations: 6 sites (Kaohsiung City and 5 other locations)
• Trial ID: NCT05771584 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and immunologic efficacy of AST-301, a therapeutic cancer vaccine, in patients with gastric cancer who have HER2 expression. Participants will be randomized into two arms, receiving either 3 or 6 cycles of the vaccine administered every three weeks. The study aims to monitor safety and disease-free survival following treatment. It includes pre-screening and screening procedures to ensure eligibility based on specific criteria related to prior treatments and cancer staging.

Who should consider this trial

Good fit: Ideal candidates are gastric cancer patients with HER2 expression who have completed standard adjuvant treatment and have undergone curative surgery.

Not a fit: Patients with a history of hypersensitivity to the treatment components or those with other malignancies within the last five years may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new immunotherapy option for gastric cancer patients, potentially improving their disease-free survival rates.

How similar studies have performed: Other studies have shown promise with similar immunotherapy approaches in cancer treatment, suggesting potential for success in this trial.

Eligibility criteria

Key Inclusion Criteria:

* Underwent a curative surgery with standard lymph node dissection (confirmed with no residual tumor, R0 resection) and have completed standard adjuvant treatment
* Has stages II or III according to the 8th edition of the American Joint Committee on Cancer (AJCC)
* HER2 low expression and HER2 overexpression diagnosed according to the 2016 College of American Pathologists (CAP)/American Society for Clinical Pathology (ASCP)/American Society of Clinical Oncology (ASCO) guidelines
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
* Demonstrates adequate organ function.

Key Exclusion Criteria:

* Has a history of hypersensitivity or other contraindications to rhuGM-CSF
* Has a history of other malignancies ≤5 years prior to first administration of Investigational Product (IP) except for adequately treated non-melanoma skin cancer or epithelial carcinoma without evidence of disease.
* Has received systemic immunosuppressants or were treated with systemic immunosuppressants ≤4 weeks prior to the first administration of Investigational Product (IP).
* Has a history of autoimmune disease or inflammatory disease
* Has active infection including tuberculosis, hepatitis B, hepatitis C or human immunodeficiency virus (HIV) infection
* Is pregnant or breastfeeding or expecting to conceive children

Where this trial is running

Kaohsiung City and 5 other locations

• Kaohsiung Medical University Chung-Ho Memorial Hospital — Kaohsiung City, Taiwan (Recruiting)
• China Medical University Hospital — Taichung, Taiwan (Recruiting)
• Taichung Veterans General Hospital — Taichung, Taiwan (Recruiting)
• Chi Mei Medical Center — Tainan, Taiwan (Recruiting)
• Taipei Veterans General Hospital — Taipei, Taiwan (Recruiting)
• Chang Gung Memorial Hospital Linkou — Taoyuan, Taiwan (Recruiting)

Study contacts

• Study coordinator: Hun Jung, MD, PhD

Conditions Gastric Cancer